Debashish Roy, Ph.D. Email & Phone Number

Durham, North Carolina, Us

• Proficient in the GLP-compliant environment's analytical and molecular biology techniques.• Assisted in preparing and reviewing study reports supporting regulatory documentation related to product development, especially CMC sections of the IND filings and BLA enabling studies towards submission, ensuring alignment with the regulatory expectations.• Managed and reviewed regulatory compliance documentation, test protocols, and validation documents, ensuring compliance with both internal and external regulatory expectations.• Authored formulation and stability protocols for biologics drugs aligned with regulatory requirements (e.g. FDA, ICH). • Participated in internal regulatory inspection readiness, addressing regulatory gaps and driving corrective and preventive actions to maintain compliance with industry regulations and quality standards. • Worked in collaboration with quality assurance (QA), core facilities, and analytical development teams to ensure all stages of product development complied with regulatory standards.

Winston-Salem, Nc, Us

• Five plus years’ hands-on work experience with Capillary electrophoresis and chromatography techniques; method development, optimization and validation.• Developed ssDNA aptamer sensor for the toxicological screening of controlled/toxic compounds in the patient urine sample by way of Capillary electrophoresis• Optimized Capillary electrophoresis-based DNA aptamer-target separations employing fluorescent carbon nanoparticles• Identified and isolated target-specific aptamer using Next-generation sequencing (NGS)• Performed statistical analysis of spectroscopy data using R for data interpretation and visualization• Collaborated with researchers in chemistry department and our industry research partner• Mentored junior graduate student researchers with lab techniques and GLP training

Columbia, Md, Us

• Performed method development and validation for pain medications on Agilent Technologies, Waters, Thermo Scientific, and SCIEX LC/MS/MS platforms.• Review, tabulate, and conduct statistical analysis and data modeling using SAS and R programming languages on research and production data.• Developed and validated methods for pain medications • Developed method for analyzing illicit drugs found in patient samples.• Conduct experiments to assess utility of novel experimental technologies• Develop Statistical Models of Medication Data to discern drug distribution patterns, and enhance patient care• Utilize R’s Statistical Software Package, and other statistical tools and programming languages

Uppsala, Uppsala Län, Se

• Experienced in studying antimicrobial resistance in Mycobacterium tuberculosis and Staphylococcus aureus against synthesized medicinal products, utilizing BSL-2 and -3 lab environments in collaboration with a university hospital.• Studied vector-borne illness involving dengue fever and epidemiology of Zika virus among Asian population.• Research focused on synthesizing stable and minimalized antimicrobial plant peptides (AMP) and assessing their activity via bioassay.• Engineered and synthesized peptide variants for the diagnosis of rheumatoid arthritis.• Performed antimicrobial peptide and protein purification and identification using LC-MS/MS

Dhaka, Bd

• Performed in formulation development for oral (tablet), injectable, and inhalation (MDI) drugs.• Designed and conducted experiments for assay procedure development and validation on GC, LC MS/MS, UPLC, etc., dissolution, and stability studies.• Assisted in preparing and reviewing regulatory documents, performed internal audits, and writing standard operating procedures (SOPs) following cGMP guidelines.• Maintained analytical instruments by routine maintenance, troubleshooting, calibration.

Bd

• Performed in formulation development for oral (tablet, capsules), topical, and injectable drugs.• Designed and conducted experiments for assay method development and validation on GC, LC-MS/MS, UPLC, KF, AAS, etc., dissolution and stability studies.• Conducted raw materials analysis to determine the purity and quality of API• Assisted in preparing and reviewing regulatory documents, performed internal audits, and writing standard operating procedures (SOPs) following cGMP and GLP guidelines.• Maintained analytical instruments by routine maintenance, troubleshooting, calibration.

Basel, Baselstadt, Ch

• Developed multi-particulate dosage forms using various manufacturing techniques• Prepared work model and characterized developed formulation for in-vitro performance• Participated in globally recognized GMP and GLP training program

Regulatory Affairs

Doctor Of Philosophy - Phd, Bioanalytical Chemistry

Master'S In Medical Science, Infection Biology

Bachelor Of Pharmacy (Honors), Pharmacy